Category: Blog

The emergence of a novel coronavirus, SARS-CoV-2, the virus which causes COVID-19, has set off a cascading series of public health reactions unpresented in modern times. International travel shuttered to a halt as public health professionals sought the control the spread of COVD-19 through the traditional paradigm of identifying, isolating, and controllingcases. On the international stage, the World Health Organization (WHO) declared the 6^th Public Health Emergency of International Concern since the 2005 revision of the International Health Regulations. In this context, a new set of authorities and liabilities schemes rapidly become applicable.

The ultimate goal in the control of any communicable disease is the development of a safe and effective vaccine capable of reducing morbidity and mortality. To encourage rapid innovation, medical countermeasures benefit from an array of traditional and pandemic-specific alternative liability structures. For the past 35 years, the National Vaccine Injury Compensation Program (VICP) has created an alternative liability structure for adverse events temporally connected to routine vaccination. Funded by a $0.75 excise tax on each disease prevented per vaccine dose, a pool of funding is available to compensate victims of certain vaccine related injuries. Originally created by the National Childhood Vaccine Injury Act of 1986, the VICP requires injured parties to present their claims to the U.S. Court of Federal Claims for a special master to adjudicate. The law requires the Department of Health and Human Services (HHS) to create a Vaccine Injury Table listing covered vaccines and adverse events. Injuries sufficiently linked to a covered can generally receive economic and non-economic damages.

A key element of the government’s response to a major emergency is the invocation of special authorities. Beginning on March 17, 2020, HHS issued the first of several declarations under the Public Readiness and Emergency Preparedness (PREP) Act. Among other things, the PREP Act provides extensive immunity to medical countermeasures, including “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID–19.” This immunity bars nearly all suits, absent willful misconduct, federal enforcement actions or equitable relief, for covered persons who “prescribe, administer, or dispense” countermeasures such as the EUA approved COVID-19 vaccines. Additionally, a PREP Act declaration shifts the vaccine liability structure from the VICP to the Countermeasures Injury Compensation Program (CICP). While relatively similar in premise to VICP, CICP covers injuries from vaccines developed during the declared emergency and require congressionally allocated function. Unlike VICP, who’s decisions can be appealed to the traditional courts, decisions of the CICP are unappealable.

Beginning in the early days of the COVID-19 pandemic, more than 200 candidate vaccines were identified, and traditional vaccine technologies were expanded to include DNA, RNA, protein-based technologies. Through an initiative codenamed Operation Warp Speed, the United States (U.S.) government invested unprecedented funding into vaccine development, including manufacturing doses potentially at a loss, to ensure prompt availability of promising candidates immediately upon approval. To date, the U.S. Food and Drug Administration authorized 3 vaccines under their Emergency Use Authorization (EUA) process, and the WHO authorized 8 vaccines through their equivalent, Emergency Use Listing (EUL) process.

In routine times, a governmental interest exists in encouraging the development of lifesaving vaccines. Following adverse events in the 1980’s involving the diphtheria, tetanus and whole-cell pertussis (DTwP) and live polio vaccines, the government created an alternative liability structure to insulate vaccine developers and spur innovation in an already highly regulated industry. To further expedite innovation during a declared public health emergency, even greater authorities and liability shields can be activated. Ultimately, the unusually strong liability protections EUA COVID-19 vaccines enjoy demands the utmost public confidence in the approval process.

For more detailed analysis on vaccine liability in COVID-19, see this article.

From developments in data cloud software that enable hospital systems to improve internal efficiency to developments in nanotechnology that enable the targeting of individual cancer cells, the healthcare field benefits significantly from increased intersection and collaboration between tech and medicine. However, despite the huge potential for good that comes with this intersection, sometimes what works in a tech setting doesn’t work when applied to the development of a medical device. This is very apparent in the trial of Elizabeth Holmes, the founder of medical startup Theranos. Holmes claimed to have developed a device that could perform over 240 blood tests on a single drop of blood and have the results back to the patient within hours. This medical advancement was hailed as on par with the development of penicillin. The only problem: it was all a hoax. 

The devices simply did not work. Even when the devices succeeded in testing blood samples, the results were so wrong most of the time that they endangered patients. Imagine getting a false positive for cancer, herpes, or diabetes. Or worse: a false negative. What makes this case one that has garnered so much attention is the fact that Holmes was well aware of the devices’ inaccuracies and inadequacies: when the prototype was far from full development, she told investors that the devices were ready to be rolled out to storefronts; when employees told her the devices’ results were wildly inaccurate, she told investors they could be relied upon by doctors and patients. Many have been left asking: how could a company get so far—valued at 10 billion dollars in July 2015—when both the technology and the company were so inherently flawed?

While the answer is not simple, the ‘fake-it-till-you-make-it’ attitude widely celebrated in Silicon Valley seems to be a convincing culprit. Budding tech CEOs idolize figures like Steve Jobs, and Uber founder, Travis Kalanickfor their entrepreneurial spirit in (sometimes questionably) maneuvering their way around the rules. However, problems occur when this approach is applied to medical tech. While not having all the bugs worked out of a new ride-share app before launching might have some adverse consequences that can usually be curtailed, doing the same thing with a medical device could seriously and negatively affect hundreds of thousands of patients.

Yet, because of the cutthroat nature of Silicon Valley competition for venture capital, many tech startups, including Theranos, have relied heavily on nondisclosure agreements to ensure trade secrets are kept secret. John Carreyrou, investigative journalist largely responsible for unmasking Theranos’ fraud, describes in his book ‘Bad Blood’ how Theranos was able to silence many of its ex-employees by wrongfully leveraging nondisclosure agreements. While there are many potential legal remedies to encourage more transparency and hopefully prevent fraud like that of Theranos, better-adapting whistleblower protections to the medical tech setting seems like a promising option. 

Currently, whistleblower protections vary significantly across states. Despite wide variation, most states have some form of statute forbidding employers from discharging employees because of whistleblowing. However, employers can still easily file claims against whistleblowers for breach of nondisclosure agreements or for misappropriation of trade secrets. Though the 2016 Defend Trade Secrets Act (DTSA) endeavors to give whistleblowers immunity from claims of misappropriating trade secrets, courts have held that the statute’s immunity provision only gives the whistleblower an affirmative defense rather than sovereign immunity. Additionally, though the DTSA requires that employers inform employees of their whistleblowing immunity rights, this requirement can be satisfied simply by cross-referencing to a company policy that sets forth the provision. Lauren Rogal, legal scholar, posits that employees need to be more effectively notified of their whistleblower protections—had Theranos been required to adhere to a higher standard of notice, it’s possible that employees would have come forward sooner (page 1697). Ultimately, creating stronger requirements for notice of whistleblower protections, among other reforms, can help ensure that employees understand their rights and are empowered in keeping companies accountable. Enacting legislative reform to focus on the specific field of healthcare tech as it relates to whistleblower protections will prove incredibly important as advancements in healthcare tech continue to define the medical field.

DMDM Hydantoin is a preservative used in certain shampoos, conditioners, and other hair care products. DMDM Hydantoin functions as a formaldehyde releaser or donor. It works by slowing releasing formaldehyde over time to prevent the growth of harmful mold and bacteria as well as other microbes, therefore increasing the shelf-life of cosmetic products. According to a study done by the Actas Dermo-Sifiliográficas in Spain, the chemical has increased the risk of contact dermatitis and irritation in consumers who are already sensitive to formaldehyde exposure. 

The FDA lists DMDM hydantoin as a common allergen in personal care products. Current research on the chemical has produced varying perspectives. Formaldehyde is a known carcinogen. At high concentrations, it can cause chemical burns, though this is mostly an occupational hazard. A 1998 safety assessment found the chemical to be safe as a cosmetic ingredient at concentrations up to 1%. However, a more recent 2016 study found that formaldehyde releasers can lead to irritation at low levels of exposure. Still, other doctors claim that the levels of formaldehyde that DMDM hydantoin releases is negligible and should not be causing irritation on its own. However, this also depends on one’s sensitivity to formaldehyde; up to 11.9% of the population is allergic to formaldehyde when exposed to a 2.0% formaldehyde patch test. Sensitivity can also develop over time with repeated exposure. 

DMDM hydantoin is the current focus of class-action lawsuits against Johnson & Johnson as well as Unilever. Plaintiffs are claiming that exposure to the preservative has caused hair loss and irritation. Plaintiffs have filed two class-action lawsuits against Unilever who manufactures the TRESemmé line of hair products. The suits allege that Unilever misrepresented their product and did not adequately warn consumers of the chemical and the hair loss it could cause. Plaintiff Emily Castillo claimed that Unilever had misrepresented their TRESemmé Keratin Smooth Color Shampoo as being safe and effective. Rather than helping nourish her hair, the shampoo allegedly caused scalp irritation and hair loss. 

Similarly, plaintiff Larissa Whipple has sued Johnson & Johnson for their OGX hair care products, claiming affirmative misrepresentations where the company claimed the products would nourish, cleanse, and repair hair. Instead, they have allegedly caused hair loss and scalp irritation for thousands of consumers. Johnson & Johnson had initially announced in 2012 that they would remove DMDM hydantoin from their products by 2015, claiming that it did not meet their safety and care commitment guidelines. The company later clarified that the chemical would still be used in a “small number” of their products.             Ultimately, is DMDM hydantoin extremely dangerous? The jury is still out, in both a scientific and a legal sense. More research is needed to establish a stronger link between the formaldehyde releaser and potentially carcinogenic effects. The pending class action lawsuits are still awaiting class certification, as well. Only time will tell, but it seems prudent to pick hair care products with less potentially harmful preservatives.

Prior to the 2021 United Nations Climate Change Conference (COP26), the World Health Organization (WHO) released a special report on climate change and health. The ten recommendations in the report propose a set of priority actions from the global health community to governments and policymakers, calling on them to act with urgency on the current climate and health crises. One of the recommendations focuses specifically on creating energy systems that protect and improve climate and health in order to save lives from the harmful effects of air pollution. Not long after the WHO’s report was released, ProPublica, a nonprofit organization headquartered in New York City that focuses on investigative journalism, released what it is calling “the most detailed map ever of cancer-causing industrial air pollution.” The map is based on an analysis of Environmental Protection Agency (EPA) data and exposes the sources of cancer-causing industrial air emissions down to the neighborhood level. 

According to the Natural Resources Defense Council (NRDC), air pollution is the release of pollutants that are detrimental to human health and the planet as a whole into the air. Most air pollution comes from industrial plants burning fossil fuels for energy use and production, which releases gases and chemicals into the air. The air pollution from these industrial plants alone is elevating the cancer risk of an estimated quarter of a million Americans. The Clean Air Act(CAA) was designed to protect public health by setting pollution standards. However, the worsening impact of climate change will not only make it harder to meet these standards but will continue to exacerbate air pollution. The effects of air pollution depend on three factors: the type of pollutant(s), the length and level of exposure, and individual health risks. For example, smog can irritate the eyes and throat and also damage the lungs. Even worse, people who suffer from asthma or allergies can experience asthma attacks and intensified symptoms. Soot can penetrate the lungs and bloodstream and worsen bronchitis, lead to heart attacks, and even hasten death. Benzene can cause leukemia and ethylene oxide can lead to lymphoma and breast cancer. 

Over the last couple of decades, study after study has found that the burden of air pollution is not evenly shared and has impacted racial minorities at a much higher rate. These findings are corroborated by the “hot spots” identified in ProPublica’s map, which are disproportionately Black. These disparities have roots in historical practices, such as redlining. According to an organizer for the Sierra Club, “[c]ommunities of color, especially Black communities, have been concentrated in areas adjacent to industrial facilities and industrial zones, and that goes back decades and decades, to redlining.” The COVID-19 pandemic has further contributed to the burden placed on these communities. The already high rates of respiratory and cardiac illnesses due to air pollution have contributed to the disproportionate toll the pandemic has taken on communities of color. The overwhelming message from COP26 has been that we have reached a turning point and bold legislation addressing longstanding racial disparities as a top concern for climate policy will be critical not only in combatting environmental racism but in saving the world. 

For the foreseeable future, in the absence of a universal vaccine mandate, a large minority of U.S. citizens will likely remain unvaccinated. As courts across the country impose vaccine requirements for juries — requiring jurors to show proof of vaccination and dismissing them if they do not — we are faced with an important constitutional question. Does requiring vaccines violate the Sixth Amendment right to a trial by a jury of one’s peers? 

The Sixth Amendment explicitly grants criminal defendants the right to a “speedy and public trial, by an impartial jury.” The Supreme Court has ruled, most famously in Taylor v. Louisiana, that an impartial jury is one that is representative of the community, often what they refer to as a representative “cross-section.” Juries that exclude women or racial minorities have failed to pass this “cross-section” test. Today, amid the ongoing Covid-19 pandemic, we are faced with the question of whether excluding the unvaccinated fails the “cross-section” test? In other words, can a jury composed only of vaccinated jurors truly be said to be a “jury of one’s peers?” 

In most communities, the answer is no. Surely in a jurisdiction where there is a near-universal vaccination rate, you could say that a vaccinated jury is representative, but in reality, few if any of these such jurisdictions exist. Even in Marin County, CA, which has one of the highest vaccination rates of any U.S. county, only 90% of eligible residents are fully vaccinated. And the remaining 10% is not a random selection. Just as Covid-19 cases, hospitalizations, and deaths have disproportionately affected low-income people and people of color, these groups are also disproportionately unvaccinated. In most states, the percentage of vaccinated people who are black is lower than the percentage of the population that is black. An analysis of socioeconomic status reveals even more stark distinctions. People with lower income, regardless of race, are far more skeptical of the Covid-19 vaccine and thus have far lower vaccination rates. In addition, there are political considerations. On average, Republicans are far less likely to be vaccinated than Democrats. 

With this recognition of vaccine disparities, it is easy to understand how a vaccinated jury would be an inherently whiter, wealthier, more educated, and more liberal jury than one composed of a random subsection of the population. It is clear then that vaccine mandates for juries violate the “cross-section” test. Vaccinated juries are, generally speaking, not wholly representative of real communities. 

The question then becomes one of how to maintain representative juries while still protecting the health and safety of jurors, judges, attorneys, and others who interact with the judicial system. Some obvious answers may include masks, social distancing, or holding trials virtually. The latter alternative though raises its own complications and questions of access and representation. If only those jurors with internet access were selected, we would see many of the same disparities reflected. Further, if we held in-person trials and dismissed those who felt unsafe sitting on a jury alongside an unvaccinated juror, we might risk the same issue of disproportionate representation in the reverse direction, seeing more unvaccinated, younger, and more politically conservative juries. 

It is rare that something is so clearly unconstitutional, and simultaneously so difficult to address as is this problem. Still, it raises interesting questions about due process and forces an important analysis of both the historic and new racial, socioeconomic, and educational disparities present in our jury pools.

The United States healthcare sector has experienced nurse and worker shortages on and off since the 1960s, and the current COVID-19 pandemic has only worsened this phenomenon. As of April 2021, over 3,000 US healthcare workers have died due to COVID-19 since the pandemic started, and many more have left the field because of the lack of equipment, support, and increasing hours, all of which has led to extreme burn-out and fatigue. More recently, vaccine mandates imposed by the federal government, states, and private companies are now placing even more strain on healthcare workers as those unwilling to be vaccinated have been fired, have quit, or have been placed on administrative leave. 

Vaccines are an essential part of bringing America out of this pandemic, and are an important part of keeping healthcare workers safe. Healthcare providers are on the frontlines serving all people who need medical care, COVID and non-COVID patients. Although safety measures are taken, hospital staff and healthcare providers are at higher risk of COVID infection. Healthcare workers were among the first groups to be eligible for the vaccine because of their increased exposure to patients with COVID. Once vaccines were open to the public, many hospitals and governments began to implement vaccine mandates. 

Currently, thirteen states require healthcare workers, home aides, and nursing care workers to be vaccinated before treating patients. In the private sector, major healthcare providers across the country, including Kaiser Permanente, Atrium Health, and Trinity Health, have issued COVID vaccine mandates for their employees. The Center for Medicare & Medicaid Services, via the Biden-Harris Administration, mandated in early September that all Medicare and Medicaid certified facilities must vaccinate their employees to continue to receive payments and benefits from the program. Medical and religious exemptions are accepted by all of these institutions. The policy rationale behind vaccine mandates for healthcare workers is that it protects both patients and staff. Through vaccines, hospitals and clinics can slow the spread of COVID-19 and maintain a steady workforce by reducing the number of staff members who contract and transmit COVID. However, not all healthcare workers are willing to comply with these mandates.

In the last few months, healthcare facilities have fired a number of their workers for refusing to be vaccinated, and others have quit, claiming that the mandates violate their rights. On October 6, Kaiser Permanente placed over 2,000 Washington state employees on unpaid leave and have said they have until December 1, 2021, to comply or have their employment permanently terminated. The company reports they are optimistic about the situation and will continue to educate their employees on the benefit of the vaccines. At Henry Ford Health in Detroit, over 400 employees quit just this month protesting the vaccine mandate. Colorado’s health officials are contemplating extending vaccination deadlines and weakening the vaccination policy to retain providers that they would otherwise need to fire for failure to comply. These examples show the vast array of strategies employed by hospitals who are reluctant to fire their workers, but also want to keep their patients and workers safe from this destructive disease. 

Hospitals and providers are responsible for the lives and safety of their patients, and a large part of that duty is keeping healthcare workers safe and in safe working conditions. Although there is hesitancy and cases of outright refusal to comply with vaccine mandates, COVID vaccines have thus far proven to save lives and improve immune responses to exposure. Vaccinating healthcare workers helps to keep them safe and protected as they continue to provide care for patients.